The U.S. Food and Drug Administration (FDA) has announced the approval of a drug called Vascepa, which is derived from fish oil, as adjuvant therapy for those who are at risk of having cardiovascular disease.
Heart disease is one of the leading causes of death among Americans, according to the U.S. Centers for Disease Control and Prevention (CDC). The agency says, at least one American dies of a cardiovascular event every 37 seconds.
Therefore, it is important to reduce the risk of a cardiovascular event, especially in people who already have a history of heart disease.
An elevated triglyceride level is considered one of the potential risk factors of cardiovascular disease. Others include obesity, high blood pressure, diabetes, and high LDL (bad) cholesterol.
Last week, the FDA approved the use of Vascepa as an adjuvant therapy to prevent cardiovascular disease in people who have high triglyceride levels.
Vascepa is available in capsules, with an active ingredient eicosapentaenoic acid, which is an omega-3 fatty acid derived from fish oil.
The U.S. drug regulatory body said that clinicians should only recommend Vascepa to people who have an elevated triglyceride level as an adjuvant therapy to other heart medications, including cholesterol-lowering drugs.
Dr. John Sharretts said, “The FDA [recognize that] there is a need for additional medical treatments for cardiovascular disease. This approval will give [people] with elevated triglycerides and other important risk factors, including heart disease, stroke, and diabetes, an adjunctive treatment option that can help decrease their risk of cardiovascular events.”
Dr. Sharretts is the acting deputy director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.
The arteries become thick and stiff when you have a high triglyceride level, increasing your risk of experiencing a life-threatening cardiovascular event, such as a heart attack or stroke.
And Vascepa has been found safe and effective at lowering high triglyceride levels, reducing the cardiovascular risk. However, the exact mechanism of the drug is unclear.
The FDA approved Vascepa after considering its safety and efficacy profile in a clinical trial that involved more than 8,100 participants. Researchers found that people who were given the fish oil-derived drug had a reduced risk of having a cardiovascular event than those who were not given the drug.
However, the researchers noted that Vascepa was associated with an increased risk of atrial fibrillation (Afib) in some participants, requiring hospitalization. They explained that the risk was more in people with existing heart disease. Amarin Corporation, the manufacturer of Vascepa, said the drug can lower triglyceride levels by around 33 percent. The manufacturer recommends taking two Vascepa 1 g capsules or four 0.5 g capsules twice a day with food. It warned people to avoid taking the drug if they have a history of fish or shellfish allergy.
